Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer (DaeMon)

Sun Yat-sen University

Status and phase

Completed

Phase 2

Conditions

Gastric Adenocarcinoma

Treatments

Drug: Fluorouracil

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01567618

SAHMO-04

Details and patient eligibility

About

This is an open-label, phase II study to evaluate the efficacy and safety of biweekly docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line therapy.

Full description

Primary endpoint: Overall Response Rate

Secondary endpoint: Time to progression, overall survival, safety data

Enrollment

39 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed written informed consent
Patients with histologically or cytologically confirmed unresectable gastric adenocarcinoma whose ECOG performance status are 0-2
Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination
At least 3 weeks since last major surgery
At least 12 months since last adjuvant chemotherapy
At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected
Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields
Patients with reproductive potential must use effective BC;
Required Screening Laboratory Criteria:

Hemoglobin 90g/L WBC 3.5 x 109/L Neutrophils 1.5 x 109/L Platelets 100 x 109/L Creatinine 133 umol/L and creatinine clearance 60 mL/min

A probable life expectancy of at least 6 months;

Exclusion criteria

Brain metastases
Female of childbearing potential, pregnancy test is positive
Concomitant malignancies or previous malignancies other than gastric cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer
Active infection
Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk
Sexually active patients refusing to practice adequate contraception; Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) unless discussed and agreed with principal investigator
History of grade 3 or 4 toxicity to fluoropyrimidines